The US Food and Drug Administration (FDA) has approved deutetrabenazine extended-release tablets (Austedo XR, Teva), a new once-daily formulation of the drug for adults with tardive dyskinesia (TD) or chorea associated with Huntington disease (HD).
The FDA first approved deutetrabenazine (Austedo) to be given twice daily for TD and for HD in 2017, as reported by Medscape Medical News.
“For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address,” Eric Hughes, MD, PhD, executive vice president of research and development and chief medical officer at Teva, said in a news release announcing the approval.
According to the company, the new once-daily formulation of deutetrabenazine has been shown to be therapeutically equivalent to the twice-daily formulation.
It will be available in three extended-release tablet strengths: 6 mg, 12 mg, and 24 mg ― to be can be taken with or without food.
Teva expects extended-release deutetrabenazine to be available in the United States later this year.
TD is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities. The condition affects roughly 500,000 people in the United States and is caused by certain medications used to treat psychiatric disorders or gastrointestinal conditions.
HD affects more than 35,000 US individuals. About 90% of these patients experience chorea, which includes involuntary, nonrhythmic movements that appear to flow from one muscle to another.
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